Ocular implant insertion apparatus and methods

ABSTRACT

An exemplary ocular implant insertion system includes a case and a preloaded ocular implant insertion apparatus. The apparatus includes first and second movable structures that move the ocular implant in a predetermined sequence. The respective configurations of the case and the ocular implant insertion apparatus are such that the ocular implant insertion apparatus is not removable from the case when the ocular implant insertion apparatus is in the pre-use state and is removable after the first movable structure has moved at least a portion of the optical implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/071,880, filed Mar. 16, 2016, which is a continuation of U.S.application Ser. No. 14/145,846, filed Dec. 31, 2013, now U.S. Pat. No.9,314,373, which is a continuation of U.S. application Ser. No.13/699,708, now U.S. Pat. No. 8,647,382, which has a 35 U.S.C. §371(c)date of May 11, 2013 and is a U.S. national phase application under 35U.S.C. §371 of International Patent Application No. PCT/JP2011/063747,filed Jun. 8, 2011, which claims priority to Japanese patent applicationNo. 2010-132952, filed Jun. 10, 2010. The International Application waspublished in English on Dec. 15, 2011 as International Publication No.WO 2011/155636 A1. The content of each application is incorporatedherein in its entirety.

BACKGROUND OF THE INVENTIONS

1. Field of the Inventions

The present inventions relate generally to apparatus and methods forinserting an ocular implant into an eye.

2. Description of the Related Art

There are a variety of instances where an ocular implant is insertedinto the anterior chamber, posterior chamber, cornea, vitreous spaceand/or other portion of an eye. Exemplary ocular implants include, butare not limited to, lenses, capsular tension rings, ocular prosthesisand lamellar transplants. An intraocular lens (IOL), for example, may beinserted into an aphakic eye that has undergone a cataract surgery ormay be inserted into a phakic eye during a refractive surgery. One typeof lens is a foldable lens. Foldable lenses are formed from softmaterial such as a silicone elastomer, soft acrylic, or hydrogel and maybe inserted into the eye through a small incision. Lens insertionapparatus, which may be used to push a foldable lens into an eye througha nozzle, generally include screw-type insertion apparatus and push-typeinsertion apparatus. In both cases, the lens insertion apparatus mayinclude a plunger that is used to push a folded lens through the nozzleinto the eye by way of an incision that is relatively small, e.g., anincision that is smaller than the diameter of an IOL optic.

Loading an ocular implant into an inserter can be a troublesome portionof the insertion procedure. The implant may be contaminated, damaged orimproperly placed into the inserter by operator, e.g., a surgeon orassistant. Accordingly, in some instances, the insertion apparatus ispreloaded, i.e., the insertion apparatus is shipped from the factorywith the ocular implant (e.g., an IOL) stored therein. An operator usinga preloaded inserter does not place the implant into the insertionapparatus, thereby eliminating the possibility of the aforementionedoperator error associated with loading.

In addition to the basic functions of storing and inserting an IOL orother ocular implant, it may also be desirable for the insertionapparatus to minimize the physical load on the ocular implant duringstorage in order to ensure that the ocular implant returns to itsunstressed state after being inserted into the eye. It may also bedesirable to fold the IOL or other ocular implant into as small a stateas possible in order to reduce the size of the incision and thelikelihood of corneal astigmatism caused by the surgery or infection.Thus, the desired insertion apparatus must be able to fold theunstressed ocular implant into a small state in a predetermineddirection, and into a predetermined shape, in order to insure that theplunger can move the folded ocular implant through the nozzle withoutthe insertion apparatus becoming clogged at or near the nozzle or theocular implant being damaged. To that end, instead of using only aplunger to move the lens through the folding and insertion processes,some insertion apparatus have been configured to fold and move an IOL instepwise fashion through the use of multiple IOL moving structures.Examples of such insertion apparatus are illustrated and described inPCT Pub. No. WO 2009/148091 (also published as US 2011/0082463) andLaid-open JP Pat. Pub. No. 2001-104347 (also published as US2001/0007942).

The present inventor has, however, determined that insertion apparatuswith multiple ocular implant moving structures are susceptible toimprovement. For example, the present inventor has determined that suchinsertion apparatus are susceptible to erroneous operation, such as useof the moving structures in an incorrect sequence.

SUMMARY

An exemplary ocular implant insertion system includes a case and anocular implant insertion apparatus including an ocular implant, a firstmovable structure that moves at least a portion of the ocular implantduring movement thereof, and a second movable structure that moves theocular implant through the nozzle. The ocular implant insertionapparatus is located at least partially within the case in pre-use statewherein the first and second movable structures have not folded andmoved the ocular implant. The respective configurations of the case andthe ocular implant insertion apparatus are such that the ocular implantinsertion apparatus is not removable from the case when the ocularimplant insertion apparatus is in the pre-use state and is removableafter the first movable structure has moved at least a portion of theoptical implant.

An exemplary method of using a system including a case and a preloadedocular implant insertion apparatus locked to the case includes the stepsof unlocking the insertion apparatus from the case by moving a firstmovable structure a distance sufficient to at least partial fold astored ocular implant, removing the insertion apparatus from the case,and pushing the ocular implant from the insertion apparatus with asecond movable structure.

There are a number of advantages associated with such systems andmethods. For example, such systems and methods prevent the use of thefirst and second movable structures in an incorrect sequence.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of exemplary embodiments of the inventions will bemade with reference to the accompanying drawings.

FIG. 1 is a perspective view of an IOL insertion system, including anIOL insertion apparatus and an insertion apparatus case, in accordancewith one embodiment of a present invention.

FIG. 2 is a perspective view of the exemplary IOL insertion apparatusillustrated in FIG. 1.

FIG. 3 is a perspective view of the insertion tube of the exemplary IOLinsertion apparatus illustrated in FIG. 2.

FIG. 4 is a perspective view of the main body of the exemplary IOLinsertion apparatus illustrated in FIG. 2.

FIG. 5 is a perspective view of the lens placement section of theexemplary IOL insertion apparatus illustrated in FIG. 2.

FIG. 6 is a section view of the insertion tube and lens placementsection of the exemplary IOL insertion apparatus illustrated in FIG. 2.

FIG. 7 is a perspective view of the plunger of the exemplary IOLinsertion apparatus illustrated in FIG. 2.

FIG. 8 is a perspective view of the distal portion of the plunger rod ofthe exemplary IOL insertion apparatus illustrated in FIG. 2.

FIG. 9 is a perspective view of the exemplary insertion apparatus caseillustrated in FIG. 1.

FIG. 10 is a partial section view of a portion of the exemplary IOLinsertion system illustrated in FIG. 1.

FIG. 11 is a perspective view of the exemplary cover illustrated in FIG.1.

FIG. 12 is a perspective view showing one aspect of the operation of theexemplary IOL insertion system illustrated in FIG. 1.

FIG. 13 is a perspective view showing another aspect of the operation ofthe exemplary IOL insertion system illustrated in FIG. 1.

FIG. 14 is a partial section view showing another aspect of theoperation of the exemplary IOL insertion system illustrated in FIG. 1.

FIG. 15 is a perspective view showing another aspect of the operation ofthe exemplary IOL insertion system illustrated in FIG. 1.

FIG. 16 is a perspective view showing another aspect of the operation ofthe exemplary IOL insertion system illustrated in FIG. 1.

FIG. 17 is a perspective view of another exemplary IOL insertionapparatus that may be combined with a case in the manner illustrated inFIG. 1 to form an IOL insertion system.

FIG. 18 is a perspective view of an IOL insertion system, including anIOL insertion apparatus and an insertion apparatus case, in accordancewith one embodiment of a present invention.

FIG. 19 is a perspective view of the insertion tube of the exemplary IOLinsertion apparatus illustrated in FIG. 18.

FIG. 20 is a perspective view of a portion of the exemplary IOLinsertion system illustrated in FIG. 18.

FIG. 21 is a perspective view of a portion of the slider and the lensplacement section of the exemplary IOL insertion apparatus illustratedin FIG. 18.

FIG. 22 is a perspective view of the lens placement section of theexemplary IOL insertion apparatus illustrated in FIG. 18.

FIG. 23 is a perspective view of a portion of the slider of theexemplary IOL insertion apparatus illustrated in FIG. 18.

FIG. 24 is a perspective view of a portion of the plunger rod of theexemplary IOL insertion apparatus illustrated in FIG. 18.

FIG. 25 is a side view of a portion of the exemplary IOL insertionapparatus illustrated in FIG. 18.

FIG. 26 is a perspective view of an IOL insertion system, including anIOL insertion apparatus and an insertion apparatus case, in accordancewith one embodiment of a present invention.

FIG. 27 is a side view of a portion of the exemplary IOL insertionsystem illustrated in FIG. 26.

FIG. 28 is a side view of a portion of the exemplary IOL insertionsystem illustrated in FIG. 26.

FIG. 29 is a side view of a portion of the exemplary IOL insertionsystem illustrated in FIG. 26.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions. The presentinventions are also applicable to a wide variety of ocular implantswhich, as used herein, refers to any structure, instrumentality ordevice that is placed into any ocular structure or region. Ophthalmiclenses, capsular tension rings, ocular prosthesis and lamellartransplants are examples of ocular implants. Although the exemplaryimplementations are described below in the context of an intraocularlens (IOL), the present inventions are also applicable other types ofocular implants, including those yet to be developed. For example, thepresent inventions are applicable to other types of ophthalmic lenses.Such lenses include, but are not limited to, intraocular contact lenses,phakic IOLs, and other lenses that may be inserted into the eye.

I. OVERVIEW

As illustrated in FIG. 1, the exemplary IOL insertion system 1 includesan IOL insertion apparatus 2A and a case 3 in which the IOL insertionapparatus 2A is stored during shipping and at other times prior to aninsertion procedure. The IOL insertion apparatus 2A is a preloadedinsertion apparatus and, to that end, an IOL 40 (FIG. 5) is placedwithin the insertion apparatus during the assembly process and theinsertion apparatus is shipped and stored with the IOL located therein.The IOL insertion system 1 includes a lock mechanism 4 that prevents theIOL insertion apparatus 2A from being removed from the case 3 when in alocked state, and allows the IOL insertion apparatus to be removed fromthe case when in an unlocked state. As is discussed in greater detailbelow, the operation of the IOL insertion apparatus 2A itself is,generally speaking, a two-step process where the steps must be performedin the proper sequence. The first step involves folding a previouslyunstressed IOL into a particular configuration with a first device andthe second step pushing the folded IOL though a tapered passage, whereit is further folded, and then into the eye. The IOL insertion system 1is configured such that the lock mechanism 4 will transition from thelocked state to the unlocked state, thereby allowing the IOL insertionapparatus 2A to be removed from the case 3, when the first step isperformed. In other words, the IOL insertion system 1 is configured suchthat the operator will not be able to remove the IOL insertion apparatus2A from the case 3 unless the first step in the process has beenperformed. By requiring the first step to be performed prior to removalof the IOL insertion apparatus 2A from the case 3, the IOL insertionsystem 1 forces the operator to perform the steps in the correct order.

II. EXEMPLARY IOL INSERTION APPARATUS

Turning to FIG. 2, the exemplary IOL insertion apparatus 2A includes aslider 6, a plunger 8A, a main body 14A and an insertion tube 16 that ismounted on the forward end of the main body. The main body 14A andinsertion tube 16 together define the external housing of the insertionapparatus 2A. The slider 6 and plunger 8A are movable relative to theexternal housing and relative to each other.

Operation of the IOL insertion apparatus 2A, where the IOL is pushed outof the apparatus and into the eye, is referred to herein as a “push-out”or “insertion” process. The slider 6, which has a pair of finger grips7, performs the first step in the insertion process, i.e., folding apreviously unstressed IOL into a particular configuration, and maytherefore be referred to as one example of a first lens push-outmechanism. The exemplary slider 6 pushes the IOL 40 distally as it foldsthe IOL. In other implementations, the first “push-out” mechanism mayperform the first step of the “push-out” process by simply folding anIOL without moving it distally. The exemplary plunger 8A performs thesecond step in the insertion process, i.e., pushing the folded IOLthrough a tapered lumen and then into the eye, and may therefore bereferred to as one example of a second lens push-out mechanism. The IOLmoves along a lens advancement axis A during the insertion process.Movement of the movable components of the insertion apparatus 2A and theIOL 40 towards the eye is referred to herein as movement in the forward(or “distal”) direction and movement away from the eye is referred toherein as movement in the rearward (or “proximal”) direction. Similarly,the end of a structure that faces the eye during use is referred to asthe forward (or “distal”) end and the other end the structure isreferred to as the rearward (or “proximal”) end. The slider 6 andplunger 8A are both movable in the forward and rearward directionsrelative to the main body 14A.

The exemplary insertion tube 16 includes a nozzle 18, a transitionsection 20 and a protector 22, with interior regions that are incommunication with one another so that an IOL can pass therethrough. Theinsertion tube 16 is connected to the main body 14A by a connectorarrangement 15 (FIG. 3) on the insertion tube and a correspondingconnector arrangement 17 (FIG. 4) on the main body. The inner diameterof the transition section 20 tapers downwardly from the end adjacent tothe protector 22 to the end adjacent the nozzle 18. The protector 22 hasan injection port 24 for viscoelastic material and a first insertionhole 26 (discussed below).

Turning to FIG. 4, the exemplary main body 14A includes a tubular member19, a lens placement section 28, a slider guide section 30 and aprotrusion 32. The lens placement section 28 (described below withreference to FIG. 5) protrudes distally from the front end of thetubular member 19. The slider guide section 30 is configured to allowthe slider 6 to move forwardly and rearwardly. The slider guide section30 may be a pair of slits, formed in the tubular member 19, that areparallel to the lens advancement axis A. The slider guide section 30also extends rearwardly from the distal end of the tubular member 19 tothe central portion of the tubular member. The plunger 8A is threadedlyconnected to the main body 14A in the illustrated implementation. Tothat end, the exemplary main body 14A includes a male screw. Theprotrusion 32, which is transverse to the lens advancement axis A,defines a portion of the screw thread of the male screw and a portion ofthe outer surface of the tubular member 19 defines the root of thethread. Another protrusion (not shown) may be located on the tubularmember 19 180 degrees offset from the tubular member 32.

As shown in FIG. 5, the IOL insertion apparatus 2A may be used to storean IOL 40 that has an optic 42 and a pair of supports 44 and 46 such as,for example, the illustrated pair of haptics. The exemplary lensplacement section 28 includes a bottom surface 34, a pair of side walls36 respectively located on opposite sides of the bottom surface andextending upwardly from the bottom surface, and a pair of rails 38. Thebottom surface 34 and the side walls 36 are parallel to the lensadvancement axis A and the lens advancement axis A is located betweenthe side walls. The side walls 36 each include, near the upper end, aninclined surface 36A. The rear portions of the side walls 36 includeinward protrusions 48 that prevent the IOL 40 from moving in therearward direction. The lens supporting surfaces of the rails 38 areoriented in a direction that is transverse to the lens advancement axisA and slope away from the axis A in the rearward to forward direction.As such, the stored IOL 40 is tilted relative to the lens advancementaxis A, with the forward end of the IOL optic 42 closer to the bottomsurface 34 than the rearward end. The lens supporting surfaces of therails 38 are also located a sufficient distance above the bottom surface34 to prevent the IOL optic 42 from coming into contact with the bottomsurface (note FIG. 6).

It should be noted that references herein to “top,” “bottom,” “upward,”“downward” and the like are merely references to the illustratedorientation and/or the relationship of the components relative to oneanother in the illustrated orientation. For example, the side of the IOL40 facing the bottom surface 34 is referred to “the downward side” andmovement toward the bottom surface is referred to as movement in the“downward direction,” while the opposite side of the IOL 40 is referredto as “the upward side” and movement away from the bottom surface 34 isreferred to as movement in the “the upward direction.”

In addition to the grips 7, and referring to FIGS. 5 and 14, theexemplary slider 6 includes an elongate member 9, with a lens contactsurface 5, that is carried within the main body 14A and is slidablerelative thereto. The grips 7 are connected to elongate member 9. Thelens contact surface 5, which is larger than the plunger distal end 55(discussed below), is used to scoop up the proximal IOL support 46during the initial folding of the IOL 40. A lens holder 11 is pivotablymounted on the distal end of elongate member 9 and includes a protrusion13. The lens holder 11 controls the initial folding of the IOL 40 duringthe first step of the lens insertion process. More specifically, as theslider 6 moves distally, the protrusion 13 rides along the tapered innersurface of the transition section 20, which causes the lens holder 11 topivot downwardly into contact with the IOL optic 42 to fold the IOL 40.The slider elongate member 9 also includes a slot 21 through which theplunger rod 51 (discussed below) passes during the second step of theinsertion process. Additional discussion concerning the use of a lensholder to fold an IOL may be found in, for example, U.S. Pat. Pub. No.2010/0185206.

Referring to FIG. 6, the protector 22 of exemplary insertion tube 16includes protrusions 50, with inclined surfaces 50A, that extenddownwardly and inwardly from both sides of the protector inner surface.The projections 50, which guide the insertion tube 16 onto the upperends of the side walls 36 during assembly, are sized such that theinclined surfaces 50A extend beyond the side wall inclined surface 36A.This prevents the outer edge of the IOL optic 42 located in the lensplacement section 28 from becoming wedged between the protrusions 50 andthe side walls 36.

Turning to FIG. 7, the exemplary plunger 8A includes an operationalmember 49A and a rod 51 with a distal rod portion 52, a proximal rodportion 53, and a rod distal end 55. The distal rod portion 52, which issized such that it can be inserted through the nozzle 18, may beconnected to, or may be integral with, the proximal rod portion 53. Theoperational portion 49A includes a handle 54 that is generallycylindrical in shape. The proximal (or “rearward”) end of the handle 54is rotatably journaled, or is otherwise rotatably secured, to theproximal (or “rearward”) end of the proximal rod portion 53. The handle54 is also hollow and configured to receive the proximal portion of themain body 14A. The inner surface of the handle 54 includes a femalescrew (not shown) with threads that operationally correspond to thethreads on the male screw associated with the main body 14A (noteprotrusion 32 in FIG. 4). As such, after the plunger 8A has been moveddistally from the position illustrated in FIG. 2 until the male threaddefined in part by the protrusion 32 engages the female thread withinthe handle 54, further distal movement is accomplished by rotating thehandle.

As illustrated for example in FIG. 8, the rod distal end 55 may have alens contact portion 56 and a recess 58 in which the free end of theproximal IOL support 46 is located during the second step of thetwo-step process. The exemplary lens contact portion 56 is a planarsurface that is perpendicular to the lens advancement axis A, and isprovided on a lower portion of the rod distal end 55. The exemplaryrecess 58, which has an opening 59 on one lateral side and a wall 60 onthe other lateral side, is located above the lens contact portion 56.The recess 58 may be formed by cutting (or otherwise removing) materialfrom the rod distal portion 52, starting at the distal end 55, or bymolding the rod in the illustrated configuration. The wall 60 engagesthe outer edge of the IOL optic 42 and prevents optic of the folded IOL40 from entering the recess 58. The wall 60 also keeps the IOL support46 within the recess 58. The distal end of the wall 60 may be in thesame plane as the lens contact portion 56 (as shown) or may be locateddistally beyond the lens contact portion 56.

With respect to operation of the exemplary IOL insertion apparatus 2A,and as alluded to above, the IOL 40 is initially pushed forwardly (ordistally) and folded into a predetermined shape with the slider 6. Theslider 6 also forms part of the lock mechanism 4 that locks the IOLinsertion apparatus 2A to the case 3 and, as is discussed below, theinitial forward movement of the slider, unlocks the lock mechanism. Thefolded IOL 40 is subsequently pushed by the plunger 8A forwardly (ordistally) through the transition section 20 where it is further folded,then thorough the nozzle 18, and then into the eye. In other words, theexemplary IOL insertion apparatus 2A deforms an IOL that has beenpreloaded within the main body 14A and insertion tube 16 into apredetermined shape while moving the IOL in the forward direction, firstby using the slider 6 and second by using the plunger 8A, and thendischarges the folded IOL into the eye. The IOL 40 may be folded byoperation of the slider 6 into the predetermined shape in which theoptic 42 is curled up and around the lens advancement axis A, with anupper surface of the optic dented downwardly, and in which the free endsof the supports 44 and 46 are tucked into the upper surface of thecurled optic 42 (note FIG. 14).

III. EXEMPLARY CASE

The case 3, which protects the IOL insertion apparatus 2A duringshipping and storage, may be an elongated container with an open upperend. To that end, and referring to FIG. 9, the exemplary case 3 includesa pair of end walls 61, a pair of side walls 63 that each extend fromone end wall to the other, and a bottom wall 65 (FIG. 10) at the bottomends of the end and side walls. The top ends of the end walls 61 andside walls 63 define the open upper end 67 of the case 3. The frontportion of the case 3 is identified by reference numeral 62 and the rearportion of the case is identified by referent numeral 64. The front andrear portions 62 and 64 may be separable structures that are secured toone another during the assembly process (note joint 57) as is discussedbelow.

The case 3 also includes a portion of the lock mechanism 4 that locksthe IOL insertion apparatus 2A to the case. In the illustratedembodiment, each of the side walls 63 includes a storage slot 66 andremoval slot 68. The storage slots 66 are separated, in the upwarddirection, from the open upper end 67 of the case by projections 69. Theremoval slots 68 extend to and through the upper end 67 of the case 3,and each storage slot 66 extends to the adjacent removal slot.Engagement members 70, which are located at the lower end of eachremoval slot 68, may be detachably engaged with a cover 10 (FIG. 1) tosecure the cover to the case 3. A handle 72 may be located on the rearend wall 61 and used to remove the IOL insertion system 1 from thesterile package in which it is stored. The slider grips 7 arerespectively located within the storage slots 66 when the lock mechanism4 is in a locked state (FIG. 1) and are located within the removal slotswhen the lock mechanism is in an unlocked state (FIG. 13). The width ofthe slider grips 7 (in the direction of axis A) is less than or equal tothe width of the removal slots 68. The respective configurations of theIOL insertion apparatus 2A and case 3 are also such that the slidergrips 7 can be located within the storage slots 66 when the slider 6 isin its retracted, storage location (FIG. 12) and can also be pusheddistally beyond the storage slots 66 to the point at which the slider 6has completed the initial folding of the IOL 40 (FIG. 13).

With respect to the locked state, the projections 69 prevent the slidergrips 7 and, therefore, the IOL insertion apparatus 2A, from moving inthe upward direction identified by arrow A in FIGS. 12 and 13. Theprojections 69 do not, on the other hand, prevent the slider grips 7from moving upwardly when the slider grips are located within theremoval slots 68.

The exemplary case 3 also includes structure that helps control theinitial folding of the lens during the movement of the slider 6 movesfrom the position illustrated in FIG. 12 to the position illustrated inFIG. 13. To that end, and referring to FIG. 10, the front portion 62 ofthe exemplary case 3 includes a protrusion 74 that extends through acorrespondingly sized and located insertion hole 75 on the bottomsurface of the insertion tube 16. The exemplary protrusion 74 has anoverall ellipsoidal shape that is elongate in a direction parallel tothe lens advancement axis A, and has a rearward facing surface that isslanted upwardly in the lens advancement (i.e., proximal to distal)direction. The protrusion 74 is located within the path of the IOL 40and used to deflect the distal IOL support 44, as is discussed belowwith reference to FIG. 14. The protrusion 74 is removed from the IOLpath, by way of the insertion hole 75, when the IOL insertion apparatus2A is removed from the case 3.

It should also be noted here that the front portion 62 of the exemplarycase 3 may include one or more support walls 90 (two in the exemplaryembodiment) with slots 92 in which the insertion tube 16 is supported(FIG. 10). The width of each slot 92 (in a direction perpendicular tothe lens advancement axis A) is equal to the width of the portion of theinsertion tube 16 that is located therein. Similarly, the rear portion64 includes a wall 94 (FIG. 15) with a slot 96 that is smaller in widththan, and located distally of, the distal end of the handle 54. As aresult, the IOL insertion apparatus main body 14A, insertion tube 16 andhandle 54 may not be moved forward (i.e., in the direction of arrow B inFIG. 12) when the insertion apparatus 2A is located within the case 3.Also, as discussed above, the insertion apparatus 2A may not be pulledout of the case 3 (i.e., in the direction of arrow A in FIGS. 12 and 13)when the slider grips 7 are within the storage slots 66.

The exemplary cover 10, which is shown in detail in FIG. 11, includes aflat main body 76 and a pair of clips (or other attachment devices) 78.The clips 78 are size and positioned such that they can be located inthe removal slots 68, and are configured to interlock with theengagement members 70 on the case 3. The clips 78, which extenddownwardly from and are perpendicular to the main body 76, areresiliently deflectable about the main body at the point at which theclips are attached to the main body. As a result, the cover 10 can beeasily secured to and removed from the case 3 by pressing the top endsof the clips 78 toward one another.

A protrusion 80 (FIG. 10), which extends downwardly from the bottomsurface of the main body 76, is located such that it will extend intothe first insertion hole 26 on the insertion tube 16 when the IOLinsertion apparatus 2A is located within the case 3 and the cover 10 issecured to the case. The protrusion 80 is located within the path of theIOL adjacent to the distal end of the IOL optic 42 and, therefore,prevents distal movement of the IOL 40 within the lens placement section28 during shipping and other times prior to use. The protrusion 80 isremoved from the IOL path when the cover 10 is removed from the case 3.The cover 10 also includes an injection port opening 82 that will bealigned with insertion tube injection port 24 when the IOL insertionapparatus 2A is located within the case 3 and the cover 10 is secured tothe case.

The cover 10 may be attached to the case 3, with each of the clips 78located with a portion of a removal slot 68 and secured to an engagementmember 70, when the lock mechanism 4 is in the locked state illustratedin FIG. 1. The clips 78 are also positioned forward of the slider grips7, thereby preventing the slider 6 from being moved forwardly to unlockthe lock mechanism 4 and move the IOL 40, when the cover 10 is securedto the case 3.

IV. ASSEMBLY

The exemplary IOL insertion system 1 may be assembled from an IOLinsertion apparatus 2A and case 3 in a variety of ways. One exemplaryassembly methods begins with an IOL insertion apparatus 2A that iscomplete, but for the loading of the IOL 40 and the attachment of theinsertion tube 16 to the main body 14A, and the front and rear portions62 and 64 of the case 3 separated from one another. In the initial stepof the exemplary assembly method, the slider 6 and plunger 8 areattached to the main body 14A and the slider 6 is moved to its forwardposition so that the grip will be located within the removal slots 68.The main body 14A is then attached to the rear portion 64 of the case 3,which is still separated from the front portion 62, and the slider 6 ismoved to the rearward position with the grips 7 within the storage slots66. The IOL 40 is then placed in the lens placement section 28, with theouter edge of the optic 42 on the rails 38, and the supports 44 and 46located distally and proximally of the optic. The inward protrusions 48(FIG. 5) prevent the IOL 40 from moving in the rearward direction. Theinsertion tube 16 may then be attached to the front end of the main body14A such that the lens placement section 28 is covered by the protector22.

Next, the cover 10 is inserted onto the case 3. The clips 78 movethrough the removal slots 68 until they clip onto the engagement members70, thereby securing the cover 10 to the case 3. The cover protrusion 80will now extend through the first insertion hole 26 and be positionedbetween the forward support 44 and the optic 42 of the IOL 40. As aresult, movement of the IOL 40 is held between the lens placementsection inward protrusions 48 and the cover protrusion 80 with nophysical load is applied thereto (FIG. 10). The proximal end of the casefront portion 62 is then attached to the distal end of the rear portion64 from underneath, thereby completing assembly of the exemplary IOLinsertion system 1 (FIG. 1).

V. OPERATION AND INSTRUCTIVE INDICIA

Operation of the exemplary IOL insertion system 1 is discussed belowwith reference to FIGS. 1 and 12-16. The operational method may includesa number of step that are intended to be performed in a particularorder. Some of the steps are associated with unlocking the lockmechanism 4 and removing the IOL insertion apparatus 2A from the case 3,some of the steps are associated with the operation of the IOL insertionapparatus itself, and at least one step is associated with both.

The exemplary IOL insertion system 1 may be provided with indicia thatguides the operator through the initial steps in the proper sequence.More specifically, the exemplary IOL insertion system 1 includes markers12A-12C. Each marker includes a number and, where appropriate, adirectional indicator. Marker 12A is a “1” and is located on the cover10 adjacent to the opening 82 for the injection port 24. Marker 12B,which is located on the cover 10 near the clips 78, includes a pair ofinwardly facing arrows and each arrow has a “2” associated therewith.Marker 12C may be located on one or both sides of the case 3 adjacent toone or both of the storage slots 66. In the illustrated implementation,marker 12C consists of a forwardly facing arrow and a “3” adjacent toeach of the storage slots 66 and, accordingly, each of the slider grips7 when the IOL insertion system 1 is in its initial, pre-use state. Aswill be apparent from the discussion below, the markers 12A-12C reducethe likelihood of operator error by guiding the operator through theassociated steps in the correct sequence.

The exemplary IOL insertion system 1 may be operated as follows. The IOLinsertion system may be provided to the operator in a sterile bag andremoved therefrom while holding the handle 72 (FIG. 1). A volume ofviscoelastic material sufficient to fill the region around the IOL 40may then be injected into the insertion tube 16 by way of injection port24 (note marker 12A). The ends of the cover clips 78 adjacent to themain body 76 may then be pressed together (note marker 12B) to pivot theclips away from the engagement members 70, thereby disconnecting thecover 10 from the case 3. The cover 10 may then be removed from the case3, as shown in FIG. 12. After the cover 10 has been removed from thecase 3, the clips 78 will no longer prevent the slider grips 7 frombeing moved forwardly and the protrusion 80 will no longer prevent theIOL 40 from being moved forwardly. The lock mechanism 4 will, however,still be in the locked state.

As illustrated in FIG. 13, the next step is to move the slider 6 in theforward direction (note marker 12C) until the slider grips 7 have movedout of the storage slots 66 and, in the illustrated embodiment, havecome into contact with a front ends of the removal slots 68. Suchmovement of the slider 6 causes the IOL 40 to move from the lensplacement section 28 to the transition section 20, thereby causing thelateral sides of IOL optic 42 to fold upwardly as the lens holder 11pushes the central portion of the IOL optic downwardly (FIG. 14). As theIOL 40 moves forwardly into the transition section 20, the protrusion 74bends the distal IOL support 44 such that the free end of the support ispositioned on the upper surface of the folded IOL optic 42 (FIG. 14). Inparticular, the slanted rearwardly facing surface of the protrusion 74(FIG. 10) scoops up the distal IOL support 44 as it is bent, therebyfacilitating reliable positioning of the distal IOL support on the uppersurface of the folded IOL optic 42. The lens contact surface 5 of theslider 6 also scoops up the proximal IOL support 46 and pushes itforwardly such that the proximal IOL support 46 will also be positionedon the upper surface of the folded IOL optic 42. With respect to thefolding of the IOL optic 42, the distal portion is folded to a greaterextent than the proximal portion, with the lateral edges folded up andthe center pushed down, due to the tapered shape of the interior of thetransition section 20. This completes the initial folding of the IOL 40.

Movement of the slider 6 from the position illustrated in FIG. 12 to theposition illustrated in FIGS. 13 and 14 also unlocks the lock mechanism4 because the slider grips 7 are no longer within the storage slots 66and, instead, are within the removal slots 68. The IOL insertionapparatus 2A may now be removed from the case 3 by simply lifting theapparatus in the direction identified by arrow A in FIG. 13. In additionto freeing up the IOL insertion apparatus 2A for use by the operator,removal of the IOL insertion apparatus from the case 3 also removes theprotrusion 74, which is part of the case and which facilitated reliablefolding of the IOL 40 during movement of the slider 6, from the path ofthe IOL. Thus, the protrusion 74 is located within the path of the IOL40 when needed (i.e. during the initial folding of the IOL) and isautomatically removed from the path when appropriate (i.e. prior tooperation of the plunder 8A).

Next, the operator pushes the plunger handle 54 forward in the directionof arrow B (FIG. 15) until the threads associated with the inner surfaceof the handle engage the thread (note protrusion 32 in FIG. 5) on themain body 14A. The handle 54 may then be rotated to drive the plunger8A. Forward movement of the plunger rod 51 drives the IOL 40 into, andthen through, the nozzle 18 and then into the eye (FIG. 16). The IOL 40is further folded from the state illustrated in FIGS. 14 and 15 as itmoves into the nozzle 18. The above-described initial state of thefolded IOL 40, i.e. the IOL optic 42 folded with the supports 44 and 46resting on the upper surface thereof, facilitates the subsequent foldingassociated with movement of the plunger rod 51.

It should be again emphasized here that the IOL insertion apparatus 2Ais secured to the case 3 by the lock mechanism 4 until the slider 6 hasbeen moved forward, thereby unlocking the lock mechanism so that the IOLinsertion apparatus can be removed from the case. By incorporating suchmovement of the slider 6 into the unlocking process, the present IOLinsertion system 1 prevents the operator from erroneously pushing theIOL 40 with the plunger 8A until after the IOL has undergone the initialfolding associated with the slider 6.

VI. OTHER EXEMPLARY EMBODIMENTS

The present inventions are not limited to the exemplary embodimentsdescribed above.

For example, in addition to screw-type IOL insertion apparatus such asthat described above, the present inventions are applicable to push-typeIOL insertion apparatus. One example of such a push-type IOL insertionapparatus is generally represented by reference numeral 2B in FIG. 17.The push-type IOL insertion apparatus 2B is essentially identical toapparatus 2A and similar elements are represented by similar referencenumerals. Here, however, instead of a screw-type operational member, theplunger 8B includes a push-type operational member 49B that operates ina manner similar to a syringe. Operational member 49B includes adisk-shaped member 84 on the proximal end of the proximal rod portion53, and a flange 86 on the outer surface of the main body 14B. Theplunger rod 51 is driven by resting one or more fingers on the flange 86and pushing the disk-shaped member 84 with the thumb. The IOL insertionapparatus 2B may be combined, for example, with the case 3 and cover 10described above to form an IOL insertion system that requires operationof the slider 6 prior to removal of the IOL insertion apparatus from thecase.

Another exemplary IOL insertion system, which is generally representedby reference numeral 1C in FIG. 18, includes an IOL insertion apparatus2C and a case 3C. IOL insertion system 1C is essentially identical tosystem 1 and similar elements are represented by similar referencenumbers. For example, IOL insertion system 1C includes a screw-type IOLinsertion apparatus 2C, a case 3C, a lock mechanism 4 and a cover 10C.In the interest of brevity, the discussion below focuses on thedifferences between the two systems.

As illustrated in FIG. 18, the exemplary cover 10C includes clips 78Cthat extend above the main body 76 to a greater extent than do the clips78 of the cover 10. The additional length makes the clips 78C easier togrip and the cover 10C easier to remove.

Turning to FIGS. 19 and 20, in the exemplary IOL insertion apparatus 2C,the location of the injection port 24C on the insertion tube 16Cdecreases the likelihood that the cannula (not shown) delivering theviscoelastic material will come into contact with the IOL 40.Additionally, the cover 10C is provided with a frustoconical injectionport opening 82C that will be aligned with insertion tube injection port24C when the IOL insertion apparatus 2C is located within the case 3Cand the cover is secured to the case. The frustoconical injection portopening 82C guides the cannula into the injection port 24C.

Referring to FIG. 21, the exemplary IOL insertion apparatus 2C includesa lens placement section 28C with a pair of lens covers 29 that extendover the inward protrusions 48 (FIG. 5) and portions of the IOL optic 42and proximal support 46. The lens covers 29 prevent upward movement ofthe IOL 40 prior to operation of the slider 6C (e.g., during shipping orhandling by the operator). As such, the lens covers 29 increase thelikelihood that the IOL 40 will be properly positioned when the operatorpushes the slider 6C forward. Additionally, as shown in FIG. 22, thelens placement section 28C has a bottom surface 34C with a groove 35that guides the plunger rod 51C (FIG. 24) as it passes through the lensplacement section, thereby increasing the likelihood that the plunderrod 51 will remain properly oriented.

With respect to the exemplary slider 6C, and turning to FIG. 23, theslider has a pivotable lens holder 11C with a pair of protrusions 13C.The dual protrusion arrangement causes the cause the lens holder 11C toengage the inner surface of the insertion tube 16C, and begin thepivoting and associated IOL folding, at an earlier point in the movementof the slider 6C than would be the case with the single protrusionembodiment illustrate in FIG. 14. Such earlier folding of the IOL 40helps insure that the edge of the IOL is positioned in the mannerillustrated in FIG. 14 so that the proximal IOL support 46 can slideover the IOL optic 42. With respect to deflection of the proximal IOLsupport 46, the exemplary slider 6C includes a lens contact assembly 5Cthat has a support post 5C-1 and a vertical guide surface 5C-2 thattapers outwardly in the proximal to distal direction. The lens contactassembly 5C insures that the proximal IOL support 46 will deflect in themanner described above with reference to FIG. 14.

As illustrated example in FIG. 24, the exemplary plunger rod 51C has arib 71C that extends distally to a point adjacent to the recess 58C. Therib 71C increases the rigidity of plunger rod 51C which, in turn, helpsto maintain the alignment of the plunger rod 51C. The shape of therecess 58C, which is larger than recess 58, helps insure that theproximal support 46 will move out of the recess once in the eye.

Referring to FIG. 25, the exemplary case 3C includes a support member 88that engages the bottom of the main body 14A when the IOL insertionapparatus 2C is stored within the case and the lock mechanism 4 is inthe locked state (as shown). The support member 88, which may be a thinwall with a curved upper surface, prevents the main body 14A frombending in the downward direction as the user is pushing the slider 6Cforwardly. Such bending could result in an undesirable level of frictionbetween the case 3C and the slider grip 7.

Another exemplary IOL insertion system, which is generally representedby reference numeral 1D in FIG. 26, includes an IOL insertion apparatus2D and a case 3D. IOL insertion system 1D is essentially identical tosystem 1C and similar elements are represented by similar referencenumbers. For example, IOL insertion system 1D includes a screw-type IOLinsertion apparatus 2D, a lock mechanism 4D, and a cover 10C. In theinterest of brevity, the discussion below focuses on the differencesbetween the two systems.

The present inventor has determined that there may be some instanceswhere, during the first step of the two-step process, the operator willplace the case on a table or other flat support surface, hold the frontportion of the case with one hand and the push the slider forward theother hand. Referring first to the embodiment illustrated in FIG. 18,the front portion 62 of the case 6C includes a bottom surface thattapers upwardly. If the operator pushes the front portion 62 of the case3C downwardly with too much force while firmly holding the slider grips7, the front portion of the case may deflect, the case protrusion 74 maybe completely or partially pulled out of the IOL path, and the IOLdistal support 44 may not deflect properly. The front portion 62D of theexemplary case 3D illustrated in FIGS. 26 and 27 includes a flat bottomsurface 98, which is aligned with the flat bottom surface 100 of therear portion 64D, that prevents such bending.

The present inventor has also determined that there may be someinstances where the operator attempts to pull the insertion apparatusout of the case, in a direction that is slightly angled from vertical,before the slider movement has been completed and the slider has engagedthe distal wall of the removal slot. The curvature of the proximal endsof the slider grips may create a gap, between the curved proximal endsand the distal end of the storage slot protrusion (note grip 7 andprotrusion 69 in FIG. 25) that invites these attempts. Turning to FIG.28, the respective shapes of the slider grip 7D (not the flat proximalend), storage slot 66D and removal slot 68D (note extension 102) preventthe insertion apparatus 2D from being pulled out of the case 3D when theslider 6D is only in the almost fully forward position illustrated inFIG. 28. The top corner of the slider grip 7D is in contact with thebottom corner of the protrusion 69. Only after the slider 6D is moved tothe fully forward position illustrated in FIG. 29 will removal of theinsertion apparatus 2D from the case 3D be possible.

Numerous other modifications and/or additions to the above-describedpreferred embodiments would be readily apparent to one skilled in theart. It is intended that the scope of the present inventions extends toall such modifications and/or additions.

We claim:
 1. An ocular implant insertion apparatus, comprising: a mainbody configured to store an ocular implant, with an optic and haptics,such that one of the haptics is a proximal haptic and one of the hapticsis a distal haptic; a nozzle associated with the main body; and aplunger, carried within the main body and movable along a lensadvancement axis, including a rod having a proximal portion and a distalportion, the proximal portion of the rod including an operationalmember, and the distal portion of the rod including a lens contactportion and a recess for the proximal haptic that is above the lenscontact portion and that extends proximally from the lens contactportion, the recess having an first lateral side that is open, a secondlateral side that is closed by a lateral wall, and an open distal end.2. An ocular implant insertion apparatus as claimed in claim 1, whereinthe plunger includes a top wall that extends over at least a portion ofthe recess.
 3. An ocular implant insertion apparatus as claimed in claim1, wherein the plunger includes a slanted wall that defines the proximalend of the recess.
 4. An ocular implant insertion apparatus as claimedin claim 3, wherein the slanted wall is oriented at a non-perpendicularangle with respect to the lens advancement axis.
 5. An ocular implantinsertion apparatus as claimed in claim 3, wherein the slanted wallextends from the lateral wall to the first lateral side that is open. 6.An ocular implant insertion system as claimed in claim 1, furthercomprising: a slider movable relative to the plunger from a pre-useslider position to a second slider position.
 7. An ocular implantinsertion apparatus as claimed in claim 6, wherein the proximal hapticincludes a free end; and movement of the slider from the pre-use sliderposition to the second slider position moves the free end of theproximal haptic over the optic.
 8. An ocular implant insertion apparatusas claimed in claim 6, wherein the proximal haptic includes a free end;and movement of the slider from the pre-use slider position to thesecond slider position moves the free end of the proximal haptic overthe optic.
 9. An ocular implant insertion apparatus as claimed in claim1, wherein the operational portion comprises a rotatable handle.
 10. Anocular implant insertion apparatus as claimed in claim 1, wherein theoperational portion comprises a thumb rest.
 11. An ocular implantinsertion apparatus as claimed in claim 1, wherein the lens contactportion is planar.